Medication adherence and/or counterfeit detection wearable electronic device

ABSTRACT

A method to determine medication adherence may include detecting whether a wearable electronic device is in use. The method may include detecting one or more markers in sweat vapor of the user using a chemical marker sensor of the wearable electronic device. The method may include, in response to detecting that the system is in use, determining whether the user has taken a therapeutic agent that includes the one or more markers based on detecting the one or more markers in the sweat vapor.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional application of U.S. patent applicationSer. No. 15/353,738 filed on Nov. 17, 2016 and issued as U.S. Pat. No.10,524,726 on Jan. 7, 2020. The Ser. No. 15/353,738 application isincorporated herein by reference.

FIELD

Some embodiments described herein generally relate to medicationadherence and/or counterfeit detection wearable electronic devices.

BACKGROUND

Unless otherwise indicated herein, the materials described herein arenot prior art to the claims in the present application and are notadmitted to be prior art by inclusion in this section.

It is highly desirable to know whether someone taking medications isadhering to their prescription. Insurance companies and otherrisk-bearers may be particularly interested in ensuring thatprescription medications are taken by the insured. Additionally, mostmedicine recommendations are based on “standards” rather than ametabolized amount of an active ingredient or ingredients. Some methodsfor determining medication adherence include self-reporting by the usersthat are taking medications. Self-reporting methods may be cumbersome tousers and/or may be inaccurate.

The subject matter claimed herein is not limited to embodiments thatsolve any disadvantages or that operate only in environments such asthose described above. Rather, this background is only provided toillustrate one exemplary technology area where some embodimentsdescribed herein may be practiced.

BRIEF SUMMARY OF SOME EXAMPLE EMBODIMENTS

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential characteristics of the claimed subject matter, nor is itintended to be used as an aid in determining the scope of the claimedsubject matter.

Some example embodiments described herein generally relate to medicationadherence and/or counterfeit detection wearable electronic devices.According to some embodiments, such wearable electronic devices mayanalyze perspiration in the form of sweat vapor of a user to determineconcentration of one or more marker chemicals to determine whether theuser has taken a therapeutic agent such as a medication. As used herein,“sweat vapor” is to be broadly construed to include one or morechemicals and/or chemical compounds emitted at or near a skin surface ofa human or non-human (e.g., animal) being and transported there throughsweat glands and/or eccrine glands of the skin.

In an example embodiment, a system to determine medication adherence mayinclude a chemical marker sensor, a verification sensor, and aprocessor. The chemical marker sensor may be configured to detect one ormore markers in sweat vapor of a user. The verification sensor may beconfigured to detect whether the system is in use. The processor may becommunicatively coupled to the chemical marker sensor and theverification sensor and may be configured to determine whether the userhas taken a therapeutic agent that includes the one or more markersbased on signals generated by the chemical marker sensor and theverification sensor.

In another example embodiment, a method to determine medicationadherence includes detecting whether a wearable electronic device is inuse. The method also includes detecting one or more markers in sweatvapor of a user using a chemical marker sensor of the wearableelectronic device. The method also includes, in response to detectingthat the system is in use, determining whether the user has taken atherapeutic agent that includes the one or more markers based ondetecting the one or more markers in the sweat vapor.

Additional features and advantages of the disclosure will be set forthin the description which follows, and in part will be obvious from thedescription, or may be learned by the practice of the disclosure. Thefeatures and advantages of the disclosure may be realized and obtainedby means of the instruments and combinations particularly pointed out inthe appended claims. These and other features of the present disclosurewill become more fully apparent from the following description andappended claims, or may be learned by the practice of the disclosure asset forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent disclosure, a more particular description of the disclosure willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the disclosure and aretherefore not to be considered limiting of its scope. The disclosurewill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 illustrates an example environment in which some embodimentsdescribed herein can be implemented;

FIG. 2 illustrates various example implementations of a wearableelectronic device included in the environment of FIG. 1;

FIG. 3 is a block diagram of the wearable electronic device and a remoteserver of FIG. 1; and

FIG. 4 includes a flow chart of an example method to determinemedication adherence,

all arranged in accordance with at least one embodiment describedherein.

DETAILED DESCRIPTION OF SOME EXAMPLE EMBODIMENTS

Some embodiments described herein generally relate to medicationadherence and/or counterfeit detection wearable electronic devices. Suchwearable electronic devices can be embodied as wrist-worn fitnesstrackers, smartwatches, clip-on ear rings or other ear accessories,hearing aids, dermal patches, armbands, a finger rings, smartwatchbands, or other wearable electronic devices. Such wearableelectronic devices may be configured to detect, e.g., medicationadherence.

In particular, such wearable electronic devices may be configured todetect whether a user is taking prescribed medications, over the countermedications, or any other treatment substance, all of which may begenerically referred to herein as therapeutic agents. The therapeuticagents may be embodied as and/or delivered in the form of pills,capsules, inhalers, consumable liquids, dermal patches, injections,slow-release implantables, or in any other suitable form. Thetherapeutic agents may each include one or more markers that may beexcreted in sweat of the user. Example markers include generallyregarded as safe (GRAS) molecules which can be mixed together with oneor more active ingredients of the therapeutic agent.

Various marker schemes can be used to identify therapeutic agents. Forinstance one or more of the therapeutic agents may each include a singleunique marker that uniquely identifies the therapeutic agent.Alternatively or additionally, one or more of the therapeutic agents mayeach include a unique combination of two or more markers that uniquelyidentifies the therapeutic agent. Alternatively or additionally, one ormore of the therapeutic agents may each include two or more markers in aunique combination and concentrations that together uniquely identifiesthe therapeutic agent.

In some embodiments, a given therapeutic agent may include multiplemarkers with different manifestation times. For instance, a first one ofthe markers may manifest, and thus be detectable, relatively quickly(e.g., immediately) after the therapeutic agent is taken by the user,while a second one of the markers may manifest relatively slowly (e.g.,at a “normal” metabolic rate of the user) after the therapeutic agent istaken by the user. Using a combination of two such markers, embodimentsdescribed herein may determine a “diffusion equation” of the therapeuticagent for a given user, which may enable personalized dosing.

Each wearable electronic device may include a perspiration sensor todetect sweat vapor of a user, a chemical marker sensor to detect one ormore markers in the sweat vapor, and a verification sensor to detectwhether the wearable electronic device is in use, e.g., in contact withskin. After the user takes a therapeutic agent that includes one or moremarkers, the one or more markers may be excreted through the user'sskin, e.g., through the user's sweat glands and/or eccrine glands and inthe form of sweat vapor as defined above. The user's sweat vapor mayinclude the one or more markers, identities and/or quantities of whichmay be detected in the sweat vapor by the chemical marker sensor. Thechemical marker sensor may detect the one or more markers in the sweatvapor, as opposed to directly in the sweat, to avoid externalcontamination. The perspiration sensor may detect a quantity of thesweat vapor. A concentration of the one or more markers as a percentageof the sweat vapor may be determined based on the detected quantity ofeach of the one or more markers and the detected quantity of the sweatvapor. The perspiration sensor may be included in at least someembodiments in which the one or more markers include water-solublemarker chemicals. In other embodiments, the perspiration sensor may beomitted. For instance, the perspiration sensor may be omitted inembodiments in which the one or more markers include volatile organiccompounds (VOCs).

Signals from the sensors may be used in combination to determine whetherthe user has taken the therapeutic agent. For instance, if theverification sensor indicates that the wearable electronic device is inuse and the chemical marker sensor detects one or more markers in thesweat vapor, it may be determined that the user has taken thetherapeutic agent that includes the one or more markers. Alternativelyor additionally, the user wearing the wearable electronic device may bebiometrically authenticated to confirm an identity of the user, e.g., asa particular known person with a prescription for the therapeutic agent.Such embodiments may be used to monitor and/or prevent prescriptionfraud where one person is prescribed a therapeutic agent and provides itto someone else for consumption.

In some embodiments, additional information and/or signals may be usedto increase a confidence in the determination that the user has takenthe therapeutic agent. For instance, the confidence in the determinationmay be increased based on subjective data, such as input from the userthat indicates that the user has taken the therapeutic agent.Alternatively or additionally, such subjective data may include inputfrom the user that indicates a self-assessment by the user of acondition being treated by the therapeutic agent, e.g., whether thecondition is improving, which may indicate whether the user has takenthe therapeutic agent. Alternatively or additionally, the confidence inthe determination may be increased based on objective data such asobjective measurements from an accelerometer, heart rate monitor, orother sensor. Such measurements may indicate whether an expected effectof the therapeutic agent is manifest in the user, which in turn mayindicate whether the user has taken the therapeutic agent. Alternativelyor additionally, the confidence in the determination may be increasedbased on calendar information indicative of any reminders related to theuser taking the therapeutic agent, such as whether and/or when areminder to take the therapeutic agent was given by the wearableelectronic device to the user.

Information from at least the chemical sensor and the verificationsensor, and optionally from the perspiration sensor and one or moreother sources of subjective data, objective data, and/or calendarinformation may be processed locally at the wearable electronic deviceto determine whether the user has taken the therapeutic agent.Alternatively or additionally, some or all of the information may becommunicated to a remote server, e.g., in the cloud, for remoteprocessing to determine whether the user has taken the therapeuticagent. Multiple determinations of whether the user has taken thetherapeutic agent may be made over time to validate medication adherenceof the user.

Reference will now be made to the drawings to describe various aspectsof some example embodiments of the disclosure. The drawings arediagrammatic and schematic representations of such example embodiments,and are not limiting of the present disclosure, nor are they necessarilydrawn to scale.

FIG. 1 illustrates an example environment 100 in which some embodimentsdescribed herein can be implemented. The environment 100 includes a user102 and a wearable electronic device 104. The environment 100 mayadditionally include a smartphone 106, a cloud computing environment(hereinafter “cloud 108”) that includes at least one remote server 110,a network 112, one or multiple therapeutic agents 114, multiple thirdparties (not shown) and multiple wearable electronic devices (not shown)of the third parties.

The network 112 may include one or more wide area networks (WANs) and/orlocal area networks (LANs) that enable the wearable electronic device104, the smartphone 106, the cloud 108, the remote server 110, and/orother wearable electronic devices to communicate with each other. Insome embodiments, the network 112 includes the Internet, including aglobal internetwork formed by logical and physical connections betweenmultiple WANs and/or LANs. Alternately or additionally, the network 112may include one or more cellular RF networks and/or one or more wiredand/or wireless networks such as, but not limited to, 802.xx networks,Bluetooth access points, wireless access points, IP-based networks, orthe like. The network 112 may also include servers that enable one typeof network to interface with another type of network.

The environment 100 additionally includes multiple sensors. As describedin more detail below, the sensors may include at least a chemical markersensor and a verification sensor. Alternatively or additionally, thesensors may include a perspiration sensor to detect sweat vapor, abiometric authentication sensor to biometrically authenticate the userand/or one or more other sensors from which it may be determined whetheran expected effect of the therapeutic agent is manifest in the user. Forinstance, the biometric authentication sensor may include at least oneof an accelerometer to determine user-specific gait characteristics, afingerprint scanner to determine user-specific fingerprintcharacteristics, a microphone to determine user-specific voicecharacteristics, a camera or other image sensor to detect user-specificimage characteristics (e.g., facial characteristics), or anelectrocardiogram (ECG) or photoplethysmograph (PPG) sensor to detectuser-specific heart beat characteristics. As another example, the one ormore other sensors may include at least one of an accelerometer, agyroscopic sensor, an ECG sensor, or a PPG sensor to detectmanifestations of the expected effect of the therapeutic agent in theuser.

All of the sensors may be included in a single device, such as thewearable electronic device 104 or the smartphone 106. Alternately oradditionally, the sensors may be distributed between two or moredevices. For instance, one or both of the wearable electronic device 104or the smartphone 106 may include a sensor. Alternatively oradditionally, one or more of the sensors may be provided as separatediscrete sensors that are separate from either of the wearableelectronic device 104 or the smartphone 106. According to someembodiments, the wearable electronic device 104 or the smartphone 106may serve as a hub that receives data from the other and/or fromdiscrete sensors and processes the data and/or transmits the data to thecloud 108 for processing. Thus, one or both of the wearable electronicdevice 104 or the smartphone 106 may include a suitable networkconnection (e.g., cellular or WAN connection) to send data to and/orreceive data from the cloud 108. Alternatively or additionally, theenvironment 100 may further include a personal computer (PC) dongle, aninternet of things (IOT) appliance or other device that receives datafrom and/or sends data to the wearable electronic device 104 over arelatively limited network connection like Bluetooth and can thentransmit data to and/or receive data from the cloud 108 using a cellularconnection, WAN connection, or other suitable connection.

The wearable electronic device 104 may be embodied as a portableelectronic device and may be born by the user 102 throughout the dayand/or at other times and with one or more of its sensors (e.g., thechemical marker sensor and/or the verification sensor) in contact ornear contact with the skin at any of a variety of locations on the bodyof the user 102.

FIG. 2 illustrates various example implementations 200A-200C of thewearable electronic device 104 of FIG. 1, arranged in accordance with atleast one embodiment described herein. For instance, and with combinedreference to FIGS. 1 and 2, the wearable electronic device 104 of FIG. 1may be implemented as a fitness tracker 200A, a smartwatch 200B, or ahearing aid 200C.

The fitness tracker 200A and the smartwatch 200B may typically be wornon a wrist of the user 102 but may alternatively or additionally be wornelsewhere on an arm or leg of the user 102. Each of the fitness tracker200A and the smartwatch 200B may include an electronics package 202 or204 with one or more of the sensors described herein integrated thereinand located at or near a back side of the electronics package 202 or 204to be in contact or near contact with the skin of the user 102.

Each of the fitness tracker 200A and the smartwatch 200B additionallyincludes a watchband 206 or 208. Some fitness trackers, smartwatches,and regular watches (e.g., non-smartwatches) have removable watchbands.Embodiments described herein include wearable electronic devices 104implemented as watchbands in which one or more of the sensors describedherein may be integrated therein at or near an inside surface of thewatchband. Thus, legacy fitness trackers, smartwatches, and/or regularwatches (e.g., devices that lack the sensors described herein to detectmedication adherence) can in some embodiments be retrofitted with awatchband that includes one or more of the sensors described herein tothereby detect medication adherence.

The hearing aid 200C may include at least an inner portion 210 thatextends at least partially into an ear canal of the user 102 when inuse. The hearing aid 200C may additionally include an outer portion 210located external to the ear canal of the user 102 when in use. One ormore of the sensors described herein may be integrated into the innerportion 210 to be in contact or near contact with skin in the ear canalof the user 102. Alternatively or additionally, one or more of thesensors described herein may be integrated into the outer portion 212 tobe in contact or near contact with skin of the user's outer ear and/orwith skin of the user's head.

In some embodiments, a single given user may simultaneously use two ormore wearable electronic devices as described herein, each located at adifferent location on the user's body. Information generated by thesensors of the wearable electronic devices may be collected at one ofthe wearable electronic devices and/or at a smartphone, a PC, the remoteserver 110 of FIG. 1, or other computer device and may be timesynchronized to work together.

FIG. 2 illustrates only three example implementations of the wearableelectronic device 104 of FIG. 1. In still other embodiments, thewearable electronic device 104 of FIG. 1 may be implemented as a clip-onear ring or other clip-on ear accessory, a gauged earring, an earringwith a pin for pierced ears, eye glasses (e.g., with sensors in nosepiece, ear stems, or other location in contact with skin of user), awatchband, a dermal patch, an armband, a finger ring, a necklace,footwear (e.g., with sensors in insoles or uppers of shoes, sandals, orother footwear), or other suitable form factor that in at least someembodiments positions corresponding sensors in contact with skin of theuser. Depending on the form factor, detection of sweat vapor and/ormarkers in the sweat vapor may be detected in sweat vapor excreted assweat from skin of the user at the user's ear lobe, ear canal, outerear, behind the ear, temple, nose, front/back/side of neck or chest,palm of foot, wrist, finger, upper arm, lower arm, upper leg, lower leg,stomach, back, or virtually any other location of the user's skin.

Returning to FIG. 1, the wearable electronic device 104 may include auser interface to output data to the user 102 and/or to receive inputdata from the user. The user interface of the wearable electronic device104 may include at least one of a microphone, a speaker, a display, atouchscreen display, an accelerometer, a button, or other suitableinput/output device(s). The wearable electronic device 104 may use theuser interface e.g., to output reminders from a digital calendar orcalendar app or the like to the user 102 to take a corresponding one ofthe therapeutic agents 114, to query the user 102 regarding whether theuser 102 has taken the corresponding therapeutic agent 114 and receiveinput in response thereto, to query the user to provide aself-assessment of the condition being treated by the correspondingtherapeutic agent 114 and receive input in response thereto, or tooutput other data to or receive other data from the user 102.

The remote server 110 may include a collection of computing resourcesavailable in the cloud 108. The remote server 110 may be configured toreceive measurements, determinations, calculations, user input, or otherinformation from the wearable electronic device 104, the smartphone 106,a PC dongle, an TOT appliance, or other device in the environment 100.

FIG. 3 is a block diagram of the wearable electronic device 104 andremote server 110 of FIG. 1, arranged in accordance with at least oneembodiment described herein. Each of the wearable electronic device 104and the remote server 110 may include a processor 302A or 302B(generically “processor 302” or “processors 302”), a communicationinterface 304A or 304B (generically “communication interface 304” or“communication interfaces 304”), and a storage and/or memory 306A or306B (generically “storage 306”). Although not illustrated in FIG. 3,the smartphone 106 of FIG. 1 may be configured in a similar manner asthe wearable electronic device 104 as illustrated in FIG. 3. Forinstance, the smartphone 106 may include the same, similar, and/oranalogous elements or components as illustrated in FIG. 3.

Each of the processors 302 may include an arithmetic logic unit, amicroprocessor, a general-purpose controller, or some other processor orarray of processors, to perform or control performance of operations asdescribed herein. The processors 302 may be configured to process datasignals and may include various computing architectures including acomplex instruction set computer (CISC) architecture, a reducedinstruction set computer (RISC) architecture, or an architectureimplementing a combination of instruction sets. Although each of thewearable electronic device 104 and the remote server 110 of FIG. 3includes a single processor 302, multiple processor devices may beincluded and other processors and physical configurations may bepossible. The processor 302 may be configured to process any suitablenumber format including, but not limited to two's compliment numbers,integers, fixed binary point numbers, and/or floating point numbers, allof which may be signed or unsigned.

Each of the communication interfaces 304 may be configured to transmitand receive data to and from other devices and/or servers through anetwork bus, such as an I²C serial computer bus, a universalasynchronous receiver/transmitter (UART) based bus, or any othersuitable bus. In some implementations, each of the communicationinterfaces 304 may include a wireless transceiver for exchanging datawith other devices or other communication channels using one or morewireless communication methods, including IEEE 802.11, IEEE 802.16,BLUETOOTH®, Wi-Fi, Zigbee, near field communication (NFC), or anothersuitable wireless communication method.

The storage 306 may include a non-transitory storage medium that storesinstructions or data that may be executed or operated on by acorresponding one of the processors 302. The instructions or data mayinclude programming code that may be executed by a corresponding one ofthe processors 302 to perform or control performance of the operationsdescribed herein. The storage 306 may include a non-volatile memory orsimilar permanent storage media including a flash memory device, anelectrically erasable and programmable read only memory (EEPROM), amagnetic memory device, an optical memory device, or some other massstorage for storing information on a more permanent basis. In someembodiments, the storage 306 may also include volatile memory, such as adynamic random access memory (DRAM) device, a static random accessmemory (SRAM) device, or the like.

The wearable electronic device 104 may additionally include at least achemical marker sensor 310 (“Marker Sensor 310” in FIG. 3) and averification sensor 312. Optionally, the wearable electronic device 104may further include a perspiration sensor 308, one or more other sensors314, and a user interface 316.

The perspiration sensor 308 may be configured to detect sweat vapor of auser. In some embodiments, the perspiration sensor 208 may detect ormeasure a quantity of sweat vapor. Examples of suitable perspirationsensors 308 are marketed by SENSIRION, ST, and BOSCH as humidity andtemperature sensors and may include SENSIRION'S SHT31 SENSOR, ST'SHTS221 SENSOR, or BOSCH'S BME280 sensor.

The chemical marker sensor 310 may be configured to detect one or moremarkers in the sweat vapor. The chemical marker sensor 310 may be tunedto a particular marker or may be configured to detect multiple distinctmarkers. Alternatively or additionally, the chemical marker sensor 310may be configure detect a quantity, proportion, and/or concentration ofone or more markers. In some embodiments, the chemical marker sensor 310includes a vapor permeable and liquid impermeable membrane to allowsweat vapor to enter into a sensing volume while keeping liquid sweatand/or other potential contaminants out of the sensing volume. Thechemical marker sensor 310 may include at least one of a hot platedetector (an example of which is marketed by BOSCH as BOSCH's BME680sensor), a metal-oxide gas sensor (an example of which is marketed bySENSIRION as SENSIRION's SGPC10 sensor), a graphene nanoelectronicheterodyne sensor, an infrared sensor (e.g., a mid-infrared sensor), ora capacitive micromachined ultrasonic transducer (CMUT)-based chemicalsensor. Examples of some of the foregoing are disclosed in the followingreferences which are incorporated herein by reference: (1) Kulkarni, G.S. et al. Graphene nanoelectronic heterodyne sensor for rapid andsensitive vapour detection. Nat. Commun. 5:4376 doi: 10.1038/ncomms5376,(2) U.S. Pat. No. 9,046,650, (3) Lee, H. J., et al. Highly SensitiveDetection of DMMP Using a CMUT-based Chemical Sensor, available athttp://stanford.edu/group/khuri-yakub/publications/10_Lee_01.pdf(accessed on November 15, 2016), and (4) Gardner, J. S. et al. CMOSInterfacing for Integrated Gas Sensors: A Review. IEEE Sensors Journal,Vol. 10, No. 12, December 2010.

In some embodiments, the chemical marker sensor 310 may include or bereplaced by a sensor that measures a manifestation of a chemicalreaction that involves the one or more markers. For instance, niacin(nicotinic acid) is a GRAS compound and causes skin flush. Rather thandirectly detecting the niacin, a sensor such as a camera or other imageor optical sensor could detect a color shift at the surface of the skin,which color shift may be caused by a chemical reaction involving theniacin, to detect the niacin. Thus embodiments described herein maydetermine whether one or more markers are included in a therapeuticagent by, e.g., detecting a manifestation of a chemical reaction thatinvolves the one or more markers and/or by detecting a compound that amarker may be transformed into without directly detecting the marker.

The verification sensor 312 may be configured to detect whether thewearable electronic device 104 is in use. In some embodiments, this maybe accomplished by detecting whether the wearable electronic device 140as a whole, the perspiration sensor 308, the marker sensor 310, and/orthe verification sensor 312 is less than a threshold distance from skin(e.g., of the user 102) using an infrared sensor or other suitablesensor as the verification sensor 312. Alternatively or additionally,particular movement patterns detectable by an accelerometer and/orgyroscopic sensor as the verification sensor 312 may indicate whetherthe wearable electronic device 104 is in use. Thus, the verificationsensor 312 may include at least one of an infrared sensor, anaccelerometer, or a gyroscopic sensor. Alternatively or additionally,the verification sensor 312 may include at least one of a camera orother image sensor, a microphone or other audio sensor, or othersuitable sensor to verify when the wearable electronic device is in use.One or more of the foregoing sensors used as the verification sensor 312may alternatively or additionally be used as a biometric authenticationsensor.

Accordingly, the one or more other sensors 314 may include at least onebiometric authentication sensor configured to biometrically authenticatean identity of the user that is using the wearable electronic device104. The biometric authentication sensor may include at least one of anaccelerometer, a fingerprint scanner, a microphone, an image sensor, anECG sensor, a PPG sensor, or other sensor suitable to generate signalsthat include or from which can be derived biometric characteristics ofthe user, referred to as user-specific biometric characteristics. Theuser-specific biometric characteristics can be compared to biometriccharacteristics of a particular known person, referred to asperson-specific biometric characteristics. The particular known personmay be associated with the wearable electronic device 104 and may havethe person-specific biometric characteristics generated and stored on inthe storage 306A for subsequent biometric authentication. The particularknown person may also have, e.g., a prescription for a particulartherapeutic agent. Embodiments described herein allow detection ofmedication adherence by a user and/or authentication of the user as theparticular known person to track medication adherence of the particularknown person.

The one or more other sensors 314 may alternatively or additionallyinclude a sensor configured to detect manifestations of an expectedeffect of a therapeutic agent. For instance, if the user has arthritisand the therapeutic agent is intended to reduce inflammation, pain,and/or stiffness associated with arthritis, the one or more sensors 314may include an accelerometer, a gyroscopic sensor, or other sensor thatdetects movement or motion of the user. Pain, inflammation, and/orstiffness may affect movement or motion patterns of the user. Thus, anexpected effect of the therapeutic agent may be a reduction in pain,inflammation, and/or stiffness, which may manifest as a change in themovement pattern of the user from a first movement pattern indicative ofa first level of pain, inflammation, and/or stiffness to a secondmovement pattern indicative of a second level of pain, inflammation,and/or stiffness that is lower than the first level. Other expectedeffects may manifest in the user's body in other ways that may bedetected using other sensors, such as ECG sensors, PPG sensors,microphones or other audio sensors, and/or other sensors.

The user interface 316 may be similar or identical to the user interfacedescribed above with respect to FIG. 1. In particular, the userinterface 316 may be configured to output data to the user and/or toreceive input data from the user. The user interface 316 may include atleast one of a microphone, a speaker, a display, a touchscreen display,an accelerometer, a button, or other suitable input/output device(s).The user interface 316 may be configured e.g., to output reminders froma digital calendar or calendar app or the like to the user to take atherapeutic agent, to query the user regarding whether the user hastaken the therapeutic agent and receive input in response thereto, toquery the user to provide a self-assessment of the condition beingtreated by the corresponding therapeutic agent and receive input inresponse thereto, or to output other data to or receive other data fromthe user.

The storage 306A may include measurement data 318, one or more markersignatures 320, and/or detection results 322. The measurement data mayinclude measurements from one or more of the sensors 308, 310, 312, 314and/or information derived therefrom. The marker signatures 320 mayinclude data that associates unique markers, unique combinations ofmarkers, and/or unique proportions or concentrations thereof withparticular therapeutic agents and/or sources thereof. Thus, a particularmarker, a particular combination of multiple markers, and/or aparticular combination and proportions/concentrations of multiplemarkers that are detected together form a marker signature that can belooked up in the marker signatures 320 to identify a correspondingtherapeutic agent and/or a source thereof. Such a marker scheme mayallow authentication of therapeutic agents, e.g., as being from anauthorized or otherwise known source.

Some embodiments of the marker signatures as described herein may allowfor multiple “levels” of identification, analogous to multi-level NANDmemory cells. In a single level scheme, each detectable marker may beanalogous to a single level cell that can be either on (e.g., detected)or off (e.g., not detected). If there are n detectable markers, a totalof 2^(n) unique combinations of markers (or marker signatures) arepossible. In a multi-level scheme, each of the n detectable markers mayhave one of m possible proportions or concentrations (e.g., {1, 2, 3, 4}or {1, 2, 4, 8} or {1, 3, 5, 7} for m=2; that is, m=log2(elements)) inits on state, leading to a total of 2^(n*m) unique combinations ofmarkers and proportions (or marker signatures).

The detection results 322 may include information identifying markers,marker signatures, and/or corresponding therapeutic agents detected bythe wearable electronic device 104. Alternatively or additionally, thedetection results 322 may include a confidence level calculated formarkers, marker signatures, and/or corresponding therapeutic agentsdetected by the wearable electronic device 104. Alternatively oradditionally, the detection results 322 may include a detection time orother information of each of the markers, marker signatures, and/orcorresponding therapeutic agents detected by the wearable electronicdevice 104.

Referring to the remote server 110, it may include user data 324 and/orother data stored in the storage 306B. The user data 324 may includemeasurement data, detection results, input date, and/or other datareceived from wearable electronic devices of multiple users. In someembodiments, the wearable electronic device 104 may provide measurementdata 318 to the remote server 110 which may process the measurement data318 to detect medication adherence remotely from the wearable electronicdevice 104. Alternatively or additionally, the remote server 110 mayperform more robust or additional or different processing on some or allof the user data 324 than is performed at the wearable electronic device104. For instance, wearable electronic device 104 may make an initialdetermination about whether the user has taken a therapeutic agent basedonly on measurement data 318 from the chemical marker sensor 310, theverification sensor 312, and optionally the perspiration sensor 308. Incomparison, the remote server 110 may make a final or at least morerobust or more involved determination about whether the user has takenthe therapeutic agent based on some or all of the foregoing as well asbased on subjective input from the user (e.g., subjective input from theuser indicating whether the user has taken the therapeutic agent and/orsubjective input from the user indicating a self-assessment by the userof a condition being treated by the therapeutic agent), calendarinformation, objective measurement data indicative of whether anexpected effect of the therapeutic agent is manifest in the user, and/orother information. Alternatively, all of the processing may be performedlocally at the wearable electronic device 104.

FIG. 4 is a flowchart of an example method 400 to determine medicationadherence, arranged in accordance with at least one embodiment describedherein. The method 400 may be implemented, in whole or in part, by thewearable electronic device 104, the smartphone 106, and/or the remoteserver 110 described elsewhere herein. Alternatively or additionally,software in the form of computer-executable instructions stored in oneor both of the storage 306A or 306B of FIG. 3 may be executed by one orboth of the processor 302A or 302B to cause the corresponding processor302A and/or 302B to perform or control performance of one or more of theoperations or blocks of the method 400. The method 400 may include oneor more of blocks 402, 404, 406, and/or 408. The method 400 may begin atblock 402.

At block 402, it may be detected whether a wearable electronic device isin use. Detecting whether the wearable electronic device is in use mayinclude the verification sensor 312 of FIG. 3 detecting whether thewearable electronic device 104 is in use. For instance, detectingwhether the wearable electronic device is in use may include detectingwhether the perspiration sensor 308, the chemical marker sensor 310and/or the verification sensor 312 is less than a threshold distancefrom skin using an infrared sensor. Block 402 may be followed by block404.

At block 404, sweat vapor of a user may be detected using a perspirationsensor of the wearable electronic device. Detecting the sweat vapor ofthe user may include detecting a quantity, volume, or other measurementof the sweat vapor of the user using, e.g., the perspiration sensor 308of FIG. 3. Alternatively or additionally, detecting the sweat vapor ofthe user may include detecting the sweat vapor from at least one of: awrist of the user, an ear canal of the user, or an ear lobe of the user.In other embodiments, sweat vapor may not be detected such that block404 may be omitted. Block 404, or block 402 if block 404 is omitted, maybe followed by block 406.

At block 406, one or more markers in the sweat vapor may be detectedusing a chemical marker sensor of the wearable electronic device.Detecting the one or more markers in the sweat vapor may includedetecting the one or more markers using the chemical marker sensor 310of FIG. 3. The specific markers and/or their proportions orconcentrations that are detected by the chemical marker sensor maydepend on the particular therapeutic agent taken by the user and thespecific markers and/or their proportions or concentrations containedtherein such that detection of the specific markers and/or theirproportions or concentrations may be used to determine that the user hastaken the particular therapeutic agent. Block 406 may be followed byblock 408.

At block 408, and in response to detecting that the system is in use, itis determined whether the user has taken a therapeutic agent thatincludes the one or more markers based on detecting both the sweat vaporand the one or more markers in the sweat vapor. In some embodiments,determining whether the user has taken the therapeutic agent includescalculating a confidence level that the user has taken the therapeuticagent based on detecting both the sweat vapor and the one or moremarkers in the sweat vapor and based on at least one of: objectivemeasurement data indicative of whether an expected effect of thetherapeutic agent is manifest in the user; subjective first input datafrom the user that indicates whether the user has taken the therapeuticagent; subjective second input data from the user that indicates aself-assessment by the user of a condition being treated by thetherapeutic agent; or calendar information indicative of any remindersrelated to the user taking the therapeutic agent.

In some embodiments, detecting the one or more markers in the sweatvapor at block 406 includes detecting multiple markers in the sweatvapor. In these and other embodiments, the method 400 may furtherinclude identifying a given specific therapeutic agent taken by the userbased on both a proportion and identity of each of the multiple markersthat are detected in the sweat vapor, where the proportion and identityof the multiple markers may be unique to the given specific therapeuticagent, e.g., as a marker signature.

Alternatively or additionally, detecting the one or more markers in thesweat vapor at block 406 may include detecting at least two markers ofdifferent metabolic rates in the sweat vapor of the user. Detecting theat least two markers may include detecting a first one of the at leasttwo markers at a first time and detecting at least a second one of theat least two markers at a second time subsequent to the first time.Detection of the first one of the at least two markers at the first mayindicate that the user has taken the therapeutic agent. Detection of theat least the second one of the at least two markers at the second timerelative to the first time may indicate a metabolic rate of the user. Insome embodiments, the method 400 may further include determining ametabolic rate of the user based on the first time, the second time, ora difference between the two. By determining the metabolic rate and/orthe difference in time between detecting the first marker and the secondmarker, how quickly the therapeutic agent is metabolized by the user maybe determined as an input in personalizing dosing for the user.

In some embodiments, the method 400 may further include biometricallyauthenticating the user as a particular known person. In these and otherembodiments, biometrically authenticating the user as the particularknown person may include determining user-specific biometriccharacteristics of the user, comparing the user-specific biometriccharacteristics to person-specific biometric characteristics of theparticular known person, and determining that the user is the particularknown person in response to the user-specific biometric characteristicsmatching the person-specific biometric characteristics. Theuser-specific biometric characteristics may include at least one ofuser-specific gait characteristics, user-specific fingerprintcharacteristics, user-specific voice characteristics, user-specificimage characteristics, or user-specific heart beat characteristics. Theperson-specific biometric characteristics may include at least one ofperson-specific gait characteristics, person-specific fingerprintcharacteristics, person-specific voice characteristics, person-specificimage characteristics, or person-specific heart beat characteristics.

In some embodiments, the method 400 may further include authenticating asource and/or identity of the therapeutic agent. In these and otherembodiments, marker signatures may be used similar to barcodes touniquely identify a source (e.g., a particular pharmaceutical company)and/or identity of a therapeutic agent. Thus, authenticating the sourceand/or the identity of the therapeutic agent may include determining amarker signature of the therapeutic agent, comparing the determinedmarker signature to a unique known marker signature associated with aknown source and/or identity of a known therapeutic agent, anddetermining that the source of the therapeutic agent is the known sourceof the known therapeutic agent in response to the marker signature ofthe therapeutic agent matching the known marker signature. Determiningthe marker signature of the therapeutic agent may include identifying atleast two different markers in the sweat vapor and determining aconcentration of each of the at least two different markers.

Alternatively or additionally, the method 400 may further includedetermining a baseline measurement of the one or more markers in thesweat vapor of the user during a baseline period of time prior to theuser taking the therapeutic agent. In these and other embodiments,detecting the one or more markers in the sweat vapor may includedetermining a subsequent measurement of the one or more markers in thesweat vapor of the user subsequent to the baseline period of time. Themethod 400 may further include comparing the subsequent measurement tothe baseline measurement. Determining whether the user has taken thetherapeutic agent may include determining that the user has taken thetherapeutic agent in response to the subsequent measurement exceedingthe baseline measurement by a threshold amount.

One skilled in the art will appreciate that, for this and otherprocesses and methods disclosed herein, the functions performed in theprocesses and methods may be implemented in differing order.Furthermore, the outlined steps and operations are only provided asexamples, and some of the steps and operations may be optional, combinedinto fewer steps and operations, or expanded into additional steps andoperations without detracting from the essence of the disclosedembodiments.

Some embodiments described herein have generally been described asprocessing information generated by sensors and/or information derivedtherefrom at a wearable electronic device to determine medicationadherence and/or to detect counterfeit drugs. Alternatively oradditionally, the information generated by the sensors and/orinformation derived therefrom may be processed exclusively at asmartphone such as the smartphone 106 of FIG. 1, at a remote server suchas the remote server 110 of FIG. 1, or at another computer device todetermine medication adherence and/or to detect counterfeit drugs.Alternatively or additionally, the information generated by the sensorsand/or information derived therefrom may be processed at two or more ofa wearable electronic device, a smartphone, a remote server, or othercomputer device to determine medication adherence and/or to detectcounterfeit drugs.

Embodiments disclosed herein have generally been described in thecontext of determining medication adherence. Alternatively oradditionally, embodiments described herein may be implemented incounterfeit drug detection. For instance, some generic drugs oninternational markets may copy name brand drugs that may have patents inone or more jurisdictions in terms of, e.g., packaging, branding, etc.Pharmaceutical companies and/or other entities may use wearableelectronic devices as described herein together with user segmentation(e.g., Geography—isolating counterfeit distributors in a region orgeography, and Payer Mapping—counterfeit sourcing per pharmaceuticaldistributor) to then flag groups or individuals who claim to be takingthe name brand drug and are wearing such wearable electronic devices astaking counterfeit drugs where the wearable electronic devices do notdetect one or more markers that the pharmaceutical companies or otherentities know are in the name brand drug.

The present disclosure is not to be limited in terms of the particularembodiments described herein, which are intended as illustrations ofvarious aspects. Many modifications and variations can be made withoutdeparting from its spirit and scope, as will be apparent to thoseskilled in the art. Functionally equivalent methods and apparatuseswithin the scope of the disclosure, in addition to those enumeratedherein, will be apparent to those skilled in the art from the foregoingdescriptions. Such modifications and variations are intended to fallwithin the scope of the appended claims. The present disclosure is to belimited only by the terms of the appended claims, along with the fullscope of equivalents to which such claims are entitled. It is to beunderstood that the present disclosure is not limited to particularmethods, reagents, compounds, compositions, or biological systems, whichcan, of course, vary. It is also to be understood that the terminologyused herein is for the purpose of describing particular embodimentsonly, and is not intended to be limiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should be interpreted to mean “at least one”or “one or more”); the same holds true for the use of definite articlesused to introduce claim recitations. In addition, even if a specificnumber of an introduced claim recitation is explicitly recited, thoseskilled in the art will recognize that such recitation should beinterpreted to mean at least the recited number (e.g., the barerecitation of “two recitations,” without other modifiers, means at leasttwo recitations, or two or more recitations). Furthermore, in thoseinstances where a convention analogous to “at least one of A, B, and C,etc.” is used, in general such a construction is intended in the senseone having skill in the art would understand the convention (e.g., “asystem having at least one of A, B, and C” would include but not belimited to systems that have A alone, B alone, C alone, A and Btogether, A and C together, B and C together, and/or A, B, and Ctogether, etc.). In those instances where a convention analogous to “atleast one of A, B, or C, etc.” is used, in general such a constructionis intended in the sense one having skill in the art would understandthe convention (e.g., “a system having at least one of A, B, or C” wouldinclude but not be limited to systems that have A alone, B alone, Calone, A and B together, A and C together, B and C together, and/or A,B, and C together, etc.). It will be further understood by those withinthe art that virtually any disjunctive word and/or phrase presenting twoor more alternative terms, whether in the description, claims, ordrawings, should be understood to contemplate the possibilities ofincluding one of the terms, either of the terms, or both terms. Forexample, the phrase “A or B” will be understood to include thepossibilities of “A” or “B” or “A and B.”

The present disclosure may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the disclosure is, therefore,indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A method to determine medication adherence, the method comprising: detecting whether a wearable electronic device is in use; detecting one or more markers in sweat vapor of the user using a chemical marker sensor of the wearable electronic device; and in response to detecting that the system is in use, determining whether the user has taken a therapeutic agent that includes the one or more markers based on detecting the one or more markers in the sweat vapor.
 2. The method of claim 1, wherein: detecting the one or more markers in the sweat vapor includes detecting a plurality of markers in the sweat vapor; and the method further comprises identifying a given specific therapeutic agent taken by the user based on both a proportion and identity of each of the plurality of markers that are detected in the sweat vapor and that are unique to the given specific therapeutic agent.
 3. The method of claim 1, further comprising detecting the sweat vapor of the user using a perspiration sensor of the wearable electronic device, wherein detecting the sweat vapor of the user comprises detecting the sweat vapor from at least one of: a wrist of the user; an ear canal of the user; or an ear lobe of the user.
 4. The method of claim 1, further comprising biometrically authenticating the user as a particular known person.
 5. The method of claim 4, wherein biometrically authenticating the user as a particular known person comprises: determining user-specific biometric characteristics of the user, wherein the user-specific biometric characteristics include at least one of user-specific gait characteristics, user-specific fingerprint characteristics, user-specific voice characteristics, user-specific image characteristics, or user-specific heart beat characteristics; comparing the user-specific biometric characteristics to person-specific biometric characteristics of the particular known person, wherein the person-specific biometric characteristics include at least one of person-specific gait characteristics, person-specific fingerprint characteristics, person-specific voice characteristics, person-specific image characteristics, or person-specific heart beat characteristics; and determining that the user is the particular known person in response to the user-specific biometric characteristics matching the person-specific biometric characteristics.
 6. The method of claim 1, wherein detecting whether the wearable electronic device is in use comprises detecting whether the verification sensor is less than a threshold distance from skin using an infrared sensor.
 7. The method of claim 1, further comprising authenticating a source of the therapeutic agent.
 8. The method of claim 7, wherein authenticating the source of the therapeutic agent comprises: determining a marker signature of the therapeutic agent; comparing the determined marker signature to a unique known marker signature associated with a known source of a known therapeutic agent; and determining that the source of the therapeutic agent is the known source of the known therapeutic agent in response to the marker signature of the therapeutic agent matching the known marker signature.
 9. The method of claim 8, wherein determining the marker signature of the therapeutic agent comprises identifying at least two different markers in the sweat vapor and determining a concentration of each of the at least two different markers.
 10. The method of claim 1, wherein determining whether the user has taken the therapeutic agent includes calculating a confidence level that the user has taken the therapeutic agent based on detecting the one or more markers in the sweat vapor and based on at least one of: objective measurement data indicative of whether an expected effect of the therapeutic agent is manifest in the user; subjective first input data from the user that indicates whether the user has taken the therapeutic agent; subjective second input data from the user that indicates a self-assessment by the user of a condition being treated by the therapeutic agent; or calendar information indicative of any reminders related to the user taking the therapeutic agent.
 11. The method of claim 1, further comprising determining a baseline measurement of the one or more markers in the sweat vapor of the user during a baseline period of time prior to the user taking the therapeutic agent, wherein: detecting the one or more markers in the sweat vapor comprises determining a subsequent measurement of the one or more markers in the sweat vapor of the user subsequent to the baseline period of time; and the method further includes comparing the subsequent measurement to the baseline measurement; and determining whether the user has taken the therapeutic agent includes determining that the user has taken the therapeutic agent in response to the subsequent measurement exceeding the baseline measurement by a threshold amount.
 12. The method of claim 1, wherein detecting the one or more markers in the sweat vapor includes detecting at least two markers of different metabolic rates in the sweat vapor of the user, including: detecting a first one of the at least two markers at a first time, detection of the first one of the at least two markers indicating that the user has taken the therapeutic agent; and detecting at least a second one of the at least two markers at a second time subsequent to the first time, detection of the at least the second one of the at least two markers at the second time relative to the first time indicating a metabolic rate of the user. 